A New Haven, Connecticut, pharmacy has paid $192,000 to resolve allegations that it failed to comply with the recordkeeping requirements of the Controlled Substances Act.

Community Health Pharmacy L.L.C., an independently owned retail pharmacy established in August 2016, had been accused of failing to keep complete and accurate records of its receipt and dispensing of controlled substances between January 2022 and May 2024.

According to the Department of Justice (DOJ), which announced the settlement June 1, the pharmacy violated the statute (21 U.S.C. §842(a)(5)) by:

• failing to perform a biennial inventory, as required by 21 C.F.R. §1304.11(c);
• failing to maintain readily retrievable records, as required by 21 C.F.R. §1304.04(a);
• failing to maintain complete and accurate records of controlled substances, as required by 21 C.F.R. §1304.21(a);
• failing to execute a valid power of attorney, as required by 21 C.F.R. §1305.05(a);
• allowing an unauthorized individual to sign DEA Form 222s (order forms) on at least eight occasions, in violation of 21 C.F.R. §1305.12(d);
• failing on at least eight occasions to record on DEA Form 222s the number of commercial bulk containers furnished on each item and the dates on which the containers were received by the purchaser, in violation of 21 C.F.R. §1305.13(e);
• failing on at least 19 occasions to retain copies of each executed DEA Form 222 and have them available for inspection, as required by 21 C.F.R. §1305.17(a) and (c);
• failing on 256 occasions to retain copies of invoices and records of Schedule III-V controlled substances, as required by 21 C.F.R. §1304.04(h)(3); and
• failing on 19 occasions to record dates on which Schedule III-V controlled substances were received, as required by 21 C.F.R. §1304.21(d).

None of the $192,000 settlement amount was designated as restitution, according to the settlement agreement.

Memorandum of Agreement

As part of the settlement, Community Health Pharmacy also agreed to enter into a three-year Memorandum of Agreement (MOA) with the DEA.

According to the DOJ, the MOA was “designed to ensure future compliance with the requirements of the [Controlled Substances Act] and its implementing regulations.”

Marc H. Silverman, the acting U.S. attorney for the District of Connecticut, said, “It is vital that pharmacies comply with the recordkeeping requirements of [the statute] to help prevent diversion and keep our communities safe.” He added that his office would continue its efforts “to hold pharmacies accountable for their responsibilities under federal law.”

The settlement agreement noted that it was neither an admission of liability by the pharmacy nor a concession by the government that its claims were not well-founded.

The case was investigated by the DEA’s Office of Diversion Control with the help of the Drug Control Division of the Connecticut Department of Consumer Protection.